PharmaEssentia Corp (藥華醫藥) yesterday said that Besremi (Ropeginterferon alfa-2b), its treatment for people with polycythemia vera without symptomatic splenomegaly, has gained marketing approval from the European Medicines Agency.
The company obtained the approval with help from its partner, Austria-based AOP Orphan Pharmaceuticals AG, it said, adding that sales of Besremi in Europe could begin in the first half of this year.
PharmaEssentia has out-licensed to AOP the exclusive rights to market the drug in Europe, the Middle East, the Commonwealth of Independent States and the Baltic Assembly.
PharmaEssentia chief executive officer Lin Ko-chung (林國鐘) in October last year said that the company was preparing to deliver the first batch of 20,000 doses of Besremi to Europe, which would be enough to supply the single market’s estimated 760 patients for a year.
Each dose was expected to retail at US$2,000, Lin said.
However, the company is still finalizing royalty arrangements with AOP before sales can begin in Europe, a company official said yesterday.
Separately, Lotus Pharmaceuticals Co (美時化學製藥) yesterday announced that it has launched a generic equivalent of Suboxone, a sublingual film used to combat opioid addiction in the US.
The treatment, which contains the active ingredients buprenorphine and naloxone administered four times daily under the tongue or inside the cheek, have been made available in four strengths.
The launch took place after the US Supreme Court ruled against UK-based Indivior PLC, Suboxone’s original developer, and opened the way for generics to be sold in the US.
Lotus affiliate Alvogen Group Inc on Jan. 24 obtained final approval from the US Food and Drug Administration for the generic drug and reached an agreement with Indivior on Jan. 31 to lift the restrictions on marketing generics in the US.
Alvogen and Lotus are facing competition from other Suboxone generic makers, Dr Reddy’s Laboratories Ltd of India and Mylan NV registered in the Netherlands.
An estimated 116 Americans die every day from overdoses of prescription painkillers, heroin or synthetic products, such as fentanyl, creating a treatment market estimated at about US$24 billion, the company said last year, citing findings by the US National Center for Health Statistics.
US President Donald Trump has described the issue as an “opioid epidemic” and “health emergency” that requires immediate attention.
POWERING UP: PSUs for AI servers made up about 50% of Delta’s total server PSU revenue during the first three quarters of last year, the company said Power supply and electronic components maker Delta Electronics Inc (台達電) reported record-high revenue of NT$161.61 billion (US$5.11 billion) for last quarter and said it remains positive about this quarter. Last quarter’s figure was up 7.6 percent from the previous quarter and 41.51 percent higher than a year earlier, and largely in line with Yuanta Securities Investment Consulting Co’s (元大投顧) forecast of NT$160 billion. Delta’s annual revenue last year rose 31.76 percent year-on-year to NT$554.89 billion, also a record high for the company. Its strong performance reflected continued demand for high-performance power solutions and advanced liquid-cooling products used in artificial intelligence (AI) data centers,
SIZE MATTERS: TSMC started phasing out 8-inch wafer production last year, while Samsung is more aggressively retiring 8-inch capacity, TrendForce said Chipmakers are expected to raise prices of 8-inch wafers by up to 20 percent this year on concern over supply constraints as major contract chipmakers Taiwan Semiconductor Manufacturing Co (TSMC, 台積電) and Samsung Electronics Co gradually retire less advanced wafer capacity, TrendForce Corp (集邦科技) said yesterday. It is the first significant across-the-board price hike since a global semiconductor correction in 2023, the Taipei-based market researcher said in a report. Global 8-inch wafer capacity slid 0.3 percent year-on-year last year, although 8-inch wafer prices still hovered at relatively stable levels throughout the year, TrendForce said. The downward trend is expected to continue this year,
A proposed billionaires’ tax in California has ignited a political uproar in Silicon Valley, with tech titans threatening to leave the state while California Governor Gavin Newsom of the Democratic Party maneuvers to defeat a levy that he fears would lead to an exodus of wealth. A technology mecca, California has more billionaires than any other US state — a few hundred, by some estimates. About half its personal income tax revenue, a financial backbone in the nearly US$350 billion budget, comes from the top 1 percent of earners. A large healthcare union is attempting to place a proposal before
Vincent Wei led fellow Singaporean farmers around an empty Malaysian plot, laying out plans for a greenhouse and rows of leafy vegetables. What he pitched was not just space for crops, but a lifeline for growers struggling to make ends meet in a city-state with high prices and little vacant land. The future agriculture hub is part of a joint special economic zone launched last year by the two neighbors, expected to cost US$123 million and produce 10,000 tonnes of fresh produce annually. It is attracting Singaporean farmers with promises of cheaper land, labor and energy just over the border.
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